Cryoport Systems is the life science industry’s most trusted provider of supply chain solutions for temperature-sensitive materials, serving biopharmaceutical, IVF and surrogacy and animal health organizations around the world. Cryoport Systems' proprietary Cryoport Express® shippers, Cryoportal® Logistics Management Platform, leading-edge Smartpak™ Condition Monitoring System and geo-sensing technology paired with unparalleled logistics expertise and 24/7/365 customer support, make Cryoport Systems the end-to-end temperature controlled supply chain partner that you can trust.
Operations Technician - Cryopreservation
POSITION SUMMARY
The operations technician produces cell therapy, starts material cryopreservation, and prepares daily manufacturing activities according to standard operation procedures (SOPs) in a controlled cGMP facility.
PRIMARY RESPONSIBILITIES (include but are not limited to)
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Adhere to safety policies and SOPs, proactively identify and report unsafe conditions.
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Operate manufacturing activities in grade C and grade D cleanrooms.
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Prepare washing buffer and cryopreservation solution for manufacturing use.
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Assist with material kitting, receipt, inspection, and storage as required.
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Support execution of engineering and validation production runs.
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Complete manufacturing tasks and corresponding documentation required by cGMP.
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Identify deviations and discrepancies during the process, report to the supervisor, and assist in the investigation.
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Maintain the facility's clean and organized work area.
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Maintained facility manufacturing equipment for daily cleaning and preventive maintenance and calibration policy.
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Assisted in developing procedures and writing SOPs, forms, and training materials.
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Execute routine cleaning activities in cGMP facilities.
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Be trained and perform Environment Monitoring activities routinely.
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Assist client audit and authority inspection.
COMPETENCIES & PERSONAL ATTRIBUTES
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Good knowledge of aseptic processing skills.
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Excellent communication and collaboration skills.
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Work effectively in a team-oriented, fast-paced environment and ensure quality is met. During shifts, be able to work in a classified area with coverall PPE.
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Detail-oriented and self-motivated.
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Able to manage multi-tasks.
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Passion for and alignment with Cryoport’s mission.
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A change agent and strong collaborator who is not afraid of challenging the status quo.
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An individual brings strong core values, quality, ethics, and integrity.
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A collaborative team player who embraces and champions the culture.
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Strong work ethic and ability to deliver results and meet commitments in a dynamic environment.
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Exceptional and dynamic communications skills with the ability to inspire and influence people at all levels, build consensus and commitment, and effectively drive change throughout the organization at a rate that fits the corporate culture.
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Exceptional organizational and planning skills, analytical solid ab
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Outstanding organizational and planning skills, strong analytical abilities, and process orientation.
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Demonstrates a business process orientation to developing solutions.
QUALIFICATIONS AND EDUCATION REQUIREMENTS
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A bachelor’s degree or higher in biotechnology/biomedical is a plus.
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Able to work A.M./P.M. shifts as required.
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At least two years of cGMP experience in cell therapy industries/ pharmaceutical industries.
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Good knowledge of aseptic processing skills.
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Good knowledge of non-conformity, CAPA, and Risk assessment practices.
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Able to lift at least 50-80lbs.
Starting at $26.44/hr depending on experience. Cryoport offers excellent benefits, 401k match, and stock.